THEORETICAL FOUNDATION … 8 1.1 What is ISO 9001:2000
The Standards ISO 9001:2000 analysis …
ISO 9001:2000 is the most recent iteration of a long-established quality management standard, embraced by over 300,000 organizations globally It outlines essential criteria for implementing an effective quality management system within an organization.
• Demonstrate its ability to provide consistently a product that meets customer and applicable regulatory requirements and to:
• Address/enhance customer satisfaction through the effective application of the system, developing processes for continual improvement and the prevention of errors and mistakes
The ISO 9001: 2000 contains five requirements sections, each dealing with one of the fundamental building blocks required by any process These are:
This section outlines the essential requirements for a Quality Management System (QMS) and its documentation, which serve as the foundation for effective management Organizations must evaluate the interactions between various processes, identify necessary resources, and establish methods for measuring and monitoring these processes Additionally, an action plan must be developed to address any identified issues The section further specifies the documentation requirements for the QMS, including quality manuals, procedures, and records, as well as guidelines for proper documentation control to ensure the system operates efficiently.
Top management is responsible for overseeing the development and implementation of a Quality Management System (QMS) within the organization They must demonstrate a commitment to understanding customer requirements and ensuring compliance with statutory and regulatory standards To achieve this, top management should establish a clear quality policy and set specific objectives, followed by strategic planning to meet those goals Additionally, they must facilitate effective internal communication and regularly review the management system to ensure its ongoing effectiveness.
To effectively execute the process, it is essential to have both skilled personnel and adequate physical resources Competent individuals must perform their tasks, while the work environment and available resources should be equipped to meet customer requirements efficiently.
These are the processes necessary to produce the product or to provide the service Determine the quality & objectives for the products, requirements of customers
To ensure quality and customer satisfaction, it is essential to monitor and validate products while maintaining effective communication with customers This process involves transforming inputs into outputs, which, in the context of a service organization, could mean guiding tourists on tours across the country.
To effectively monitor system performance regarding customer satisfaction and internal management, it is essential to measure various metrics Analyzing these metrics, along with identifying any defects or performance shortfalls, offers valuable insights that can drive improvements in both systems and products.
The five essential building blocks are crucial for any process, as the absence of even one disrupts the ability to maintain a controlled process This understanding is reflected in the new standard, marking a transition towards perceiving the quality system as an interconnected series of processes.
To conduct a process analysis, begin by identifying the inputs, then examine the process through its various stages to assess control mechanisms, ensuring that the outputs align with the required standards.
When an organization receives a customer order, it initiates a process that involves specific actions to transform that order into a reservation The customer order serves as the input, while the output consists of the internal documents, resources, and services necessary to deliver the requested service.
To effectively analyze the process, it is essential to identify and evaluate the inputs, control mechanisms, and outputs involved This examination may necessitate exploring methods beyond the established documented procedures to ensure comprehensive understanding and management of the process.
Control mechanisms, such as control charts, process flow diagrams, or training programs for operatives, are essential for ensuring process effectiveness Organizations must seek evidence that these control methods are functioning properly Ultimately, the true measure of effectiveness lies in evaluating whether the process outcomes align with the initial inputs.
During the research process, the output is assessed to ensure it meets the organization's requirements, while also confirming that the methods used to achieve these results operate under the controlled conditions established by the organization.
Research of processes should result in a logical research of the activities in carrying out the various functions required to supply customers with a product or service which meets their needs
Organizations can demonstrate their quality management system's compliance with ISO 9001:2000 by allowing specific exceptions in clause 7 As stated in clause 1.2 of ISO 9001:2000, exclusions are permissible only for requirements within clause 7, provided these exclusions do not hinder the organization's ability or responsibility to deliver products that meet customer and regulatory standards.
Such exclusion may find their justification in:
The character of the organization
The character of the product
Exceeding the allowed exceptions in ISO 9001:2000 can lead to non-compliance with its standards This includes cases where regulatory requirements permit exceptions that surpass those specified by ISO 9001:2000.
The ISO 9000 Family of standards is grounded in essential Quality Management Principles, highlighting the significance of quality management in the face of rising global competition As organizations strive to maintain a competitive edge, effective quality management has become a crucial focus for leadership and management teams.
Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.[ISO 9001:2000]
To ensure effective organizational functioning, it is crucial to identify and manage interconnected activities A process is defined as an activity that utilizes resources and is managed to transform inputs into outputs Typically, the output of one process serves as the input for the subsequent process The integration of these processes, along with their interactions and management, constitutes a systematic approach within the organization.
The process approach offers significant advantages by ensuring continuous oversight of the connections between individual processes within a system This method enhances the understanding of how these processes combine and interact, ultimately leading to improved efficiency and effectiveness in achieving quality management objectives, as highlighted in ISO 9001:2000.
In a quality management system, it is crucial to prioritize understanding and fulfilling requirements, evaluate processes based on their added value, assess the performance and effectiveness of these processes, and strive for continual improvement through objective measurement.
The process-based quality management system model, as illustrated in Figure 1, highlights the critical linkages between processes outlined in clauses 4 to 8, emphasizing the significant role of customers in defining requirements To ensure customer satisfaction, organizations must evaluate information on customer perceptions regarding their fulfillment of requirements While the model encompasses all the necessary elements of the International Standard, it does not delve into detailed processes Additionally, the "Plan-Do-Check-Act" (PDCA) methodology is applicable to all processes, involving the establishment of objectives, implementation of processes, monitoring and measurement against set policies and requirements, and actions aimed at continual improvement of process performance.
Figure 1.5: Model of process–based quality management system
EXPERIMENTAL RESEARCH
Research report
The responses from senior management were systematically categorized and analyzed, alongside a thorough review of performance-related documents such as policies, manuals, operational records, website information, and memos This comprehensive approach facilitated the creation of a report supported by evidence gathered throughout the study The insights derived from the collected data and document analysis formed the basis for the findings, which will ultimately underpin the conclusions of this research.
The research report is structured around key research questions, highlighting the company's quality management system, management responsibilities, resource management, product and service realization, as well as measurement, analysis, and improvement processes.
Clauses Interview questions Yes No Comment
4.1-1 Has the organization built up and documented a QM system which corresponds to the requirements of ISO 9001?
4.1-2 Does the organization implement this
QM system, maintain it and continually improve its effectiveness ? v Shall be created
4.1-3 Does identify the processes needed for the quality management system and their application throughout the organization ? v
4.1-4 Does the organization determine the sequence and interaction of these processes? v
4.1-5 Does the organization determine criteria and methods needed to ensure that both the operation and control of these processes are effective?? v Shall be modified
4.1-6 Does the organization ensure the availability of resources and information necessary to support the operation and monitoring of these processes?? v Shall be modified
4.1-7 Are these processes monitored, measured and analyzed ?? v Shall be modified 4.1-8 Are the necessary actions implemented to achieve planned?
Results and continual improvement of these processes ? v
4.1-9 Does the organization manage these processes in accordance with the requirements of ISO 9001 ? v Shall be modified
4.1-10 Does the organization ensure the control over such processes which it outsources, if they affect product conformity with requirements? v Shall be documented
4.1-11 Can the control of such outsourced processes be recognized within the QM system? v Shall be document
Clauses Interview questions Yes No Comment
4.2.1 General: does the QM system documentation include
4.2-1 a) documented statements of a quality policy and quality objectives ? v Shall be created
4.2-2 b) a quality manual ? v Shall be created
ISO 9001‖2000? v Shall be redesign 4.2-4 d) documents needed by the organization to ensure the effective planning, operation and control of its processes? v
4.2-5 e) records required by ISO 9001-2000? v Shall be modified
4.2-6 Has the organization established quality manual and is it maintained ? v Shall be modified Does the manual quality include
4.2-7 a) the scope of the quality management system, including details of and justification for any exclusions ? v Shall be redesign
4.2-8 b) the documented procedures established for the quality management system, or reference to them? v Shall be documented
4.2-9 c) a description of the interaction between the processes of the quality management system? v
4.2-10 Are the documents required by the quality management system be controlled
4.2-11 Are the document controlled according to the requirements given in 4.2.4.‖ Control of document‖?? Is a documented procedure established to v Shall be redesign define the controls needed?
4.2-12 a) to approve documents for adequacy prior to issue? v
Clauses Interview questions Yes No Comment
4.2-13 b) to review and update as necessary and re-approve documents ? v
4.2-14 c) to ensure that changes and the current revision status of documents are identified? v Shall be documented
4.2-15 d) to ensure that relevant versions of applicable documents are available at points of use? v
4.2-16 e) to ensure that documents remain legible and readily identifiable? v
4.2-17 f) to ensure that documents of external origin are identified and their distribution controlled? v
4.2-18 g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? v
4.2-19 Are these records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system? v Shall be redesign
4.2-20 Are these records legible, readily identifiable and retrievable? v Shall be modified
4.2-21 Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? v
Does top management provide evidence of its commitment to the development and Implementation of the quality management system and continually improving its effectiveness by…
5.1-1 a) communicating to the organization v as statutory and regulatory requirements?
5.1-2 b) establishing the quality policy? v Shall be created
Clauses Interview questions Yes No Comment
5.1-3 c) ensuring that quality objectives are established? v Shall be documented 5.1-4 d) conducting management reviews? v
5.1-5 e) ensuring the availability of resources? v
5.2-1 Does the top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction ? v
Does the top management ensure that the quality policy
The organization must ensure that its quality management system is aligned with its objectives and is thoroughly documented Additionally, there should be a clear commitment to meeting all relevant requirements while continuously enhancing the system's effectiveness.
5.3-3 c) provides a framework for establishing and reviewing quality objectives? v
5.3-4 d) is communicated and understood within the organization? v
5.3-5e) is reviewed for continuing suitability? v
5.4-1 Does the top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization? v
5.4-2 Are the quality objectives measurable and consistent with the quality policy? v Shall be modified
5.4.2 Quality management system planning: Does the top management ensure that
5.4-3 a) the planning of the quality v Shall be management system is carried out in order to meet the requirements given in 4.1,
―general requirements‖ as well as the quality objectives? modified
Clauses Interview questions Yes No Comment
5.4-4 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?
5.5-1 Does the top management ensure that responsibilities and authorities are defined and communicated within the organization?
5.5.2 Management representative: Has the top management appointed a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes…
5.5-2 a) ensuring that processes needed for the quality management system are established, implemented and maintained? v Shall be documented
5.5-3 b) reporting to top management on the performance of the quality management system and any need for improvement? v Shall be documented
5.5-4 c) ensuring the promotion of awareness of customer requirements throughout the organization? v Shall be documented
5.5-5 Does the top management ensure that appropriate communication processes are established within the organization? v
5.5-6 Does the top management that communication takes place regarding the effectiveness of the quality management system? v
5.6-1 Does the top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? v
Clauses Interview questions Yes No Comment
5.6-2 Does this review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives? v
5.6-3 Are records from management reviews maintained ? v
5.6.2 Review Input: Does the input to management review include information on
5.6-4 a) results of audits? v Shall be modified
5.6-6 c) process performance and product conformity? v
5.6-7 d) status of preventive and corrective actions? v Shall be documented 5.6-8 e) follow-up actions from previous management reviews? v
5.6-9 f) changes that could affect the quality management system? v
5.6.3 Review output: Does the output from the management review include any decisions and actions related to…
5.6-11 a) improvement of the effectiveness of the quality management system and its processes? v Shall be modified
5.6-12 b) improvement of product related to customer requirements? v
6.1 Provision of resources : Does the organization determine and provide the resources needed…
6.1-1 a) to implement and maintain the quality management system and continually improve its effectiveness? v
6.1-2 b) to enhance customer satisfaction by meeting customer requirements v
Clauses Interview questions Yes No Comment
6.2-1 Is the personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience? v
6.2-2 a) Does the organizations determine the necessary competence for personnel performing works affecting product quality? v
6.2-3 b) Does the organization provide training or take other actions to satisfy these needs? v
6.2-4 c) Does the organization evaluate the effectiveness of the actions taken? v
6.2-5 d) Does the organization ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives? v
6.2-6 e) Does the organization maintain appropriate records of education, training, skills and experience? v
6.3-1 Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements? v
Does the Infrastructure include, as v
6.3-2 a) buildings, workspace and associated utilities?
6.3-3 b) process equipment (both hardware and software)? v
6.3-4 c) supporting services (such as transport or communication)? v
Clauses Interview questions Yes No Comment
6.4-1 Does the organization determine and manage the work environment needed to achieve conformity to product requirements? v
7.1-1 Does the organization plan and develop the processes needed for product realization? v
7.1-2 Is planning of product realization consistent with the requirements of the other processes of the quality management system? v
In planning product realization, Does the organization determine the following, as appropriate:…
7.1-3 a) quality objectives and requirements for the product? v
7.1-4 b) the need to establish processes, documents, and provide resources specific to the product? v
7.1-5 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? v
7.1-6 d) records needed to provide evidence that the realization processes and resulting product meet requirements? v Shall be documented
7.1-7 Is the output of this planning in a form suitable for the organization's method of operations? v
7.2.1 Determination of requirements related to the
7.2-1 a) requirements specified by the customer, including the requirements for delivery and post-delivery activities? v
7.2-2 b) requirements not stated by the customer but necessary for specified or intended use, where known? v
7.2-3 c) statutory and regulatory requirements related to the product? v
Clauses Interview questions Yes No Comment
7.2-4 d) any additional requirements determined by the organization? v
7.2.2 Review of requirements related to the product
7.2-5 Does the organization review the requirements related to the product? v
Before an organization commits to supplying a product to a customer—such as through the submission of tenders, acceptance of contracts or orders, or modifications to existing agreements—has a review been conducted?
Does this review ensure that…
7.2-8 b) contract or order requirements differing from those previously expressed are resolved? v
7.2-9 c) the organization has the ability to meet the defined requirements? v
7.2-10 Are records of the results of the review and actions arising from the review maintained v
7.2-11 Where the customer provides no documented statement of requirement, the customer requirements confirmed by the organization before acceptance? v
7.2-12 Where product requirements are changed, does the organization ensure that relevant documents are amended? v Shall be modified
7.2-13 Does the organization ensure that relevant personnel are aware of the changed requirements? v
7.2.3 Customer communication arrangements for communicating with customers in relation to…
7.2-15 b) enquiries, contracts or order handling, including amendments? v
7.2-16 c) customer feedback, including customer complaints? v
Clauses Interview questions Yes No Comment
7.3-1 Does the organization plan and control the design and development of product? v
During the design and development planning, does the organization determine…
7.3-2 a) the design and development stages? v
7.3-3 b) the review, verification and validation that are appropriate to each design and development stage? v
7.3-4 c) the responsibilities and authorities for design and development? v Shall be documented
7.3-5 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility? v Shall be designed
7.3-6 Is planning output updated, as appropriate, as the design and development progresses? v
7.3-7 Are the inputs relating to product requirements determined and records maintained ? v
7.3-9 b) applicable statutory and regulatory requirements? v
7.3-10 c) where applicable, information derived from previous similar designs? v
7.3-11 d) other requirements essential for design and development? v
7.3-12 Are these inputs reviewed for adequacy? v
Clauses Interview questions Yes No Comment
7.3-14 Are the outputs of design and development provided in a form that enables verification against the design and development input? v
7.3-15 are the design and development inputs approved prior to release? v
7.3-16 a) Do the outputs meet the input requirements for design and development? v
7.3-17 b) Do the outputs provide appropriate information for purchasing, production and for service provision? v
7.3-18 c) Do the outputs contain or reference product acceptance criteria? v
7.3-19 d) Do the outputs specify the characteristics of the product that is essential for its safe and proper use? v
7.3.4 Design and development review At suitable stages, systematic reviews of design and development is performed in accordance with planned arrangements…
7.3-20 a) to evaluate the ability of the results of design and development to meet requirements? v
7.3-21 b) to identify any problems and propose necessary actions? v
7.3-22 Do Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed? v reviews and any necessary actions maintained? documented
7.3-24 Is verification performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements? v
Clauses Interview questions Yes No Comment
7.3-25 Are records of the results of the verification and, any necessary actions maintained? v Shall be documented
Design and development validation for 7.3-26 must be conducted according to established plans to confirm that the final product meets the requirements for its intended application or use, when such details are known.
7.3-27 Wherever practicable, is validation completed prior to the delivery or implementation of the product? v
7.3-28 Are records of the results of validation and any necessary actions maintained? v
7.3.7 Control of design and development changes
7.3-29Are design and development changes identified and records maintained? v Shall be modified
7.3-30Are the changes reviewed, verified and validated, as appropriate? v
7.3-31Are the changes approved before implementation? v
7.3-32Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered? v
7.3-33Are records of the results of the review of changes and any necessary v Shall be documented actions maintained?
7.4-1 Does the organization ensure that purchased product conforms to specified purchase requirements? v
The type and extent of control applied to suppliers and purchased products should be determined by the impact these products have on subsequent product realization and the final product This ensures that quality and compliance are maintained throughout the supply chain, ultimately enhancing the overall effectiveness of the final output.
Clauses Interview questions Yes No Comment
7.4-3 Are suppliers evaluated and selected based on their ability to supply product in accordance with the organization's requirements? v
7.4-4 Have criteria for selection, evaluation and re-evaluation been established? v Shall be documented
7.4-5 Are records of the results of evaluations and any necessary actions arising from the evaluation maintained? v
7.4-6 Does the purchasing information describe the product to be purchased? v
Does this including where appropriate…
7.4-7 a) requirements for approval of product, procedures, processes and equipment? v
7.4-8 b) requirements for qualification of personnel? v
7.4-9 c) quality management system requirements? v Shall be modified
7.4-10 Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier? v
7.4-11 Does the organization establish and v implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
When the organization or its customer plans to conduct verification at the supplier's location, it is essential for the organization to clearly specify the intended verification arrangements and the method of product release within the purchasing information.
7.5.1 Control of production and service provision
7.5-1 Is production and service provision planned and carried out under controlled conditions? v
Clauses Interview questions Yes No Comment
Do the Controlled conditions include, as applicable…
7.5-2 a) the availability of information that describes the characteristics of the product? v
7.5-3 b) the availability of work instructions, as necessary? v
7.5-4 c) the use of suitable equipment? v
7.5-5 d) the availability and use of monitoring and measuring devices? v Shall be redesign 7.5-6 e) the implementation of monitoring and measurement?
Shall be modified 7.5-7 f) the implementation of release, delivery and post-delivery activities? v
7.5.2 Validation of processes for production and service provision
7.5-8 Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement? v
7.5-9 Does this includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered? v
7.5-10 Does Validation demonstrate the v ability of these processes to achieve planned results?
Does the organization establish arrangements for these processes including, as applicable
7.5-11 a) defined criteria for review and approval of the processes? v
7.5-12 b) approval of equipment and qualification of personnel? v
7.5-13 c) use of specific methods and procedures? v
7.5-16 Where appropriate, does the organization identify the product by suitable means throughout product realization? v
Clauses Interview questions Yes No Comment
7.5-17 Does the organization identify the product status with respect to monitoring and measurement requirements? v
7.5-18 Where traceability is a requirement, does the organization control and record the unique identification of the product? v
7.5-19 Does the organization exercise care with customer property while it is under the organization's control or being used by the organization? v
7.5-20 Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? v
7.5-21 If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer and records maintained? v
7.5-22 Does the organization preserve the v processing and delivery to the intended destination?
7.5-23 Does this preservation include identification, handling, packaging, storage and protection? v
7.5-24 Does preservation also apply to the constituent parts of a product? v
7.6 Control of monitoring and measuring devices
The organization is responsible for identifying the necessary monitoring and measurement activities, as well as the appropriate devices required to ensure that the product meets specified conformity requirements.
The organization must establish processes that guarantee monitoring and measurement activities are conducted consistently with the defined requirements It is essential to ensure that these processes are effectively implemented to meet compliance standards.
Clauses Interview questions Yes No Comment
Where necessary to ensure valid results, is measuring equipment …
7.6-3 a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? v
7.6-4 where no such standards exist, is the basis used for calibration or verification recorded? v
7.6-5 b) is adjusted or re-adjusted as necessary? v
7.6-6 c) Is the equipment identified to enable the calibration status to be determined? v
7.6-7 d) Is the equipment safeguarded from adjustments that would invalidate the measurement result? v
7.6-8 e) Is the equipment protected from damage and deterioration during handling, maintenance and storage? v
7.6-9 Are the validity of the previous measuring results assessed and recorded when the equipment is found not to conform to requirements ? v
7.6-10 Does the organization take appropriate action on the equipment and any product affected? v
7.6-11 Are records of the results of calibration and verification shall be maintained ? v
7.6-12 When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed? v
7.6-13 Is this undertaken prior to initial use and reconfirmed as necessary? v
8.1 General Does the organization plan and implement the monitoring, measurement, analysis and improvement processes needed……
8.1-1a) to demonstrate conformity of the product? v Shall be documented
Clauses Interview questions Yes No Comment
8.1-2 b) to ensure conformity of the quality management system? v Shall be documented
8.1-3 c) to continually improve the effectiveness of the quality management system? v Shall be documented
8.1-4 Does this include determination of applicable methods, including statistical techniques, and the extent of their use? v
The organization evaluates its quality management system's performance by monitoring customer perceptions to determine if it has effectively met customer requirements.
8.2-2.Are the methods for obtaining and v
8.2.2 Internal audit Does the organization conduct internal audits at planned intervals to determine whether the quality management system…
8.2-3 a) conforms to the planned arrangements to the requirements of this International Standard and to the quality management system requirements established by the organization? v Shall be redesign
8.2-4 b) is effectively implemented and maintained? v
8.2-5 Is an audit program planned? v Shall be modified 8.2-6 Are the status and importance of the processes and areas to be audited taken into consideration? v
8.2-7 Are the results of previous audits taken into consideration? v
8.2-8 Are the audit criteria, scope, frequency and methods defined? v
8.2-9 Does the Selection of auditors ensure objectivity and impartiality of the audit process? v
8.2-10 Does conduct of audits ensure objectivity and impartiality of the audit process? v
Clauses Interview questions Yes No Comment
8.2-11 Are the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records defined in a documented procedure? v
8.2-12 Does the management responsible for the areas being audited ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes? v
8.2-13 Do follow-up activities include the verification of the actions taken and the reporting of verification results ? v
8.2.3 Monitoring and measurement of processes
8.2-14 Does the organization apply suitable methods for monitoring and, where v applicable, measurement of the quality management system processes?
8.2-15 Does these methods demonstrate the ability of the processes to achieve planned results? v
8.2-16 When planned results are not achieved, is correction and corrective action taken, as appropriate, to ensure conformity of the product? v
8.2.4 Monitoring and measurement of product
8.2-17 Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met? v Shall be documented
8.2-18 Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements
8.2-19 Is evidence of conformity with the acceptance criteria maintained? v Shall be documented 8.2-20 Do records indicate the person(s) authorizing release of product? v
8.2-21 Do product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer? v
Clauses Interview questions Yes No Comment
8.3-1 Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery? v Shall be redesigned
8.3-2 Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure? v
Does the organization deal with nonconforming product by one or more of the following ways:…… v
8.3-3 a) by taking action to eliminate the detected nonconformity?
8.3-4 b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer? v
8.3-5 c) by taking action to preclude its original intended use or application? v
8.3-6 Are records maintained of the nature of nonconformities and any subsequent actions taken including concessions obtained? v
8.3-7 When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements? v
8.3-8 When nonconforming product is detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity? v
The organization effectively identifies, gathers, and analyzes relevant data to assess the suitability and effectiveness of its quality management system This process also aids in identifying opportunities for continuous improvement within the system.
Clauses Interview questions Yes No Comment
8.4-2 Does this include data generated as a result of monitoring and measurement and from other relevant sources? v
8.4-3 Does the analyses of data provide information relating to…… a) customer satisfaction ? v
8.4-4b) conformity to product requirements v 8.4-5c) characteristics and trends of processes and products including opportunities for preventive action? v
The organization consistently enhances the effectiveness of its quality management system by utilizing the quality policy, setting quality objectives, analyzing audit results, examining data, implementing corrective and preventive actions, and conducting management reviews.
8.5-2 Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? v
8.5-3 Are the corrective actions appropriate to the effects of the nonconformities encountered?
Is a documented procedure shall be established to define requirements for…… v
8.5-4 a) reviewing nonconformities (including customer complaints)?
8.5-5 b) determining the causes of nonconformities? v
8.5-6 c) evaluating the need for action to ensure that nonconformities do not recur? v
8.5-7 d) determining and implementing action needed? v
8.5-8 e) records of the results of action taken ? v
Clauses Interview questions Yes No Comment
8.5-10 Has the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence? v
8.5-11 Are preventive actions appropriate to the effects of the potential problems? v Shall be documented
Is a documented procedure established to v define requirements for……
8.5-12 a) determining potential nonconformities and their causes?
8.5-13 b) evaluating the need for action to prevent occurrence of nonconformities? v
8.5-14 c) determining and implementing action needed? v
8.5-15 d) records of results of action taken
AND
Research findings
The results of this study reflect a limited sample of the management system utilized at Ben Thanh Tourist, acknowledging that additional discrepancies may still exist.
The practical implementation of the standard was assessed by comparing it with the company's management system manual and related documents This evaluation involved discussions and interviews with the company's senior management.
The research examined key aspects of tour operation processes to assess the extent of management system implementation While the study was conducted with thoroughness, it was not possible to evaluate every detail of the comprehensive management system.
The company management system‘s conformity and nonconformity derived from data describe extent that Ben Thanh tourist complies with the standard requirement
The management system of Ben Thanh Tourist fails to meet the ISO 9001:2000 requirements, as evidenced by both general and specific descriptions along with interpretive commentary on the data presented.
There are 34 points of nonconformity found in its system
Figure 3.1: Concept relating to conformity [sources 9000:2000]
Data shows that Ben Thanh Tourist's quality management systems do not meet ISO standards The ISO requirements mandate that the company document, implement, and maintain its quality management system while continuously improving its effectiveness Specifically, Ben Thanh Tourist must establish a quality policy, quality objectives, a quality manual, and associated procedures Additionally, it is essential to control these documents, ensuring that employees have access to the most current versions and that outdated copies are promptly removed However, Ben Thanh Tourist has failed to adhere to these crucial requirements.
Ben Thanh has established an organizational policy; however, it lacks a commitment to meet requirements and to continually enhance the effectiveness of its quality management system Additionally, this policy is not effectively communicated or understood within the company.
The parent company established measurable objectives for Ben Thanh Tourist, which, while not fully aligned with the quality policy, serve as a motivating factor for staff to work towards achieving them.
It does not comply with the standards
Data shows that Ben Thanh Tourist's management responsibilities do not align with ISO 9001:2000 standards Compliance with this standard necessitates the development and implementation of a quality management system, along with ongoing efforts to enhance its effectiveness.
communicating to the all employees the importance of meeting customer as well as statutory and regulatory requirements,
ensuring that quality objectives are established,
ensuring the availability of resources
Ben Thanh Tourist's management partially meets the necessary requirements; however, it does not comply with ISO standards To enhance quality, it is essential to establish clear quality objectives and policies Furthermore, proper documentation of management reviews is crucial to demonstrate the management's commitment to quality.
Figure 3.2: Concept relating to documentation [sources ISO 9000:2000]
Ben Thanh Tourist has effectively identified and allocated the necessary resources to implement and sustain its quality management system, focusing on enhancing customer satisfaction by meeting client requirements Additionally, the company has recognized the essential competencies required for personnel involved in activities impacting product quality To ensure staff awareness of the significance of their roles in achieving quality objectives, Ben Thanh Tourist has provided training and evaluated the effectiveness of these initiatives.
The data also indicates that Ben thanh had determined provided and maintained the working infrastructure needed to achieve conformity to product requirements
Working Infrastructure includes buildings, workspace and associated utilities, process equipment
The data prove that these requirements are met, however it must be documented properly according to ISO 9001:2000
Ben Thanh Tourist has effectively established and developed the necessary processes for successful product realization In their planning, they have identified specific quality objectives and requirements for their products, emphasizing the importance of creating tailored processes, documentation, and resource allocation to meet these standards.
Aiming at providing services to its customers, Data and evident indicate that Ben Thanh determines the needs and expectations of customers mainly by :
in writing( email, fax, letter:
Most customers are foreign tour wholesalers and Retail travel agents Small percentages of customers are direct enquiries which are individuals
All these enquiries are handled promptly and with correct responses All information is recorded It enables Ben Thanh tourist to prepare an accurate written quotation and offers,
The information is written on a check list as follows:
Contact reference for reply (email, fax, phone
Any specials handling requirements (aged, handicapped )
Accommodation standards preferred ( specific hotel may be requested)
Any self –drive rental requirement
Tour guide and interpreter requirements
Essential itinerary inclusions( cultural, entertainments, other
Any special interest/ activities Service inclusion) The evident proves that Ben thanh determine the needs and expectation of customers in accordance with standard requirements
Aiming to provide better services to customers, Ben thanh determined necessary processes and responsibilities such as:
The reservation process involves managing inquiries and preparing quotations, followed by taking reservations and creating customer files while defining payment terms It includes booking all products and services, maintaining correspondence with both customers and suppliers, and coordinating customer files Additionally, it requires handling essential documents and creating accurate records to ensure a seamless experience for all parties involved.
The operation process involves closely monitoring the schedules of forward-booked customers and efficiently allocating transportation, accommodation, and other essential components for each group or individual booking It includes assigning drivers and tour guides, providing names lists to hotels and transportation services, and conducting thorough double-checks of all tour arrangements Additionally, it entails ongoing follow-up and problem-solving to ensure a seamless experience during the tour.
Planning and costing tour itinerary process o Itinerary planning o Costing itinerary o Booking all components of itinerary o Deposit and full payments o Handling cancelation and refund o Maintain complete record
Customer care process o Customer enquiries o Customer follow-up
Promoting and selling travel service/ tour process o Determining the needs, interests and preferences of customer o Recommendation of product o Obtaining customer agreement to buy and book
Ben Thanh Tourist has established a clear process and accountability measures to ensure customer satisfaction, aligning with standard requirements However, it is essential for the company to implement preventive actions to address potential issues and mitigate any undesirable situations that may arise.
The date shows that the Ben Thanh applied some method to monitor and measure the characteristics of the product to verify that product requirements have been met Such as
This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements
However the evidence of conformity with the acceptance criteria is not maintained Some record does not include the person who designed the tour or mended
This indicates that this should be documented properly In addition, the data indicate that Ben thanh has not determined the means of preventing nonconformities and eliminating their causes
The company fails to identify nonconformities, adopting a reactive approach instead of a proactive one Consequently, there are no preventive measures in place, and employees rely solely on their individual experiences As a result, Ben Thanh Tourist does not meet standard compliance requirements.
Figure 3.3 Concept relating to measurment management system
Recommendations
Numerous implications and recommendations for developing a quality management system that may be valuable to Ben Thanh Tourist can be drawn from this study‘s findings These are as follows:
Implementing a formal management system should be approached as a dedicated project, led by a Project Manager who is an integral part of the organization's management team and appointed from the beginning of the initiative.
Understanding the current management practices is essential before creating formal management system documentation Designing the system around existing processes is more efficient, as developing new systems may require extra resources and potentially delay implementation.
Ben Thanh Tourist may benefit from appointing a full-time Quality Manager to oversee quality management responsibilities This role is essential to keep the quality system integrated within the organization rather than isolating it within a separate department Additionally, it is crucial to maintain the system's efficiency without imposing excessive costs on the organization.
Ben Thanh Tourist offers training workshops to familiarize individuals with system requirements, particularly for those new to procedural writing This training not only ensures a comprehensive understanding of the system but also fosters a sense of ownership among employees who will implement these procedures Additionally, new hires will receive induction training focused on the quality management system.
3.2.3 Step 3 Set up quality policy and objectives:
Ben Thanh Tourist's top management demonstrates its dedication to developing and implementing an effective quality management system through a clearly defined quality policy This policy aligns with the organization's purpose, commits to compliance with requirements, and emphasizes ongoing improvement of the quality management system's effectiveness It also establishes a framework for setting and reviewing quality objectives, ensures that the policy is communicated and understood throughout the organization, and includes regular reviews to maintain its relevance.
3.2.4 Step 4: Designing the System Framework
The initial step in establishing a quality management system involves creating a framework that outlines the processes used to deliver services to both external and internal customers From this framework, the project team will identify necessary supporting documentation, focusing first on clearly defined processes and then on the competencies and procedures that will support these processes.
After designing the comprehensive framework of the quality management system and identifying the necessary documentation, it is crucial to create an implementation plan that clearly outlines the responsibilities of all participants This plan will specify the authors of the different documents, designate personnel accountable for subsequent implementation stages, and establish deadlines for completion.
3.2.5 Step 5: Developing the System of Documentation
To ensure that procedures are maintained as current documents and to reinforce the concept of ownership, it should be assigned to all system documentation
To effectively create process definitions and procedures, it is beneficial to conduct collaborative sessions involving stakeholders, guided by a management representative These brainstorming sessions facilitate idea generation, after which the management representative can draft the necessary process definitions, procedures, and competencies.
System process and procedures should reflect, as far as possible, existing working practices and identify the interfaces with the function's internal and/or external customers and suppliers
The draft processes and procedures are shared with relevant stakeholders, including customer and supplier interfaces, who are encouraged to provide feedback within a specified timeframe Additionally, they have the opportunity to participate in a finalization meeting where the process or procedure is officially approved for implementation.
The processes clearly outline the necessary tasks, the individuals responsible for completing them, and the expected outcomes or evidence of completion To support these processes, procedures and competencies are essential Instructional documents, such as work or operating instructions, specify the required methods for carrying out each activity effectively.
A quality manual is the key document for outlining and detailing a documented quality management system Its primary purpose is to provide a foundational framework for the quality management system while also serving as a reference for its development and ongoing maintenance.
The quality management manual serves as a concise overview of a company's quality management system, outlining its quality policy It includes essential structural and process organizational information, along with references to future documents such as process instructions.
Ben Thanh Tourist typically operates within a documentation system for a period of three to six months, during which it gathers essential evidence of compliance After this phase, the company is prepared to conduct its initial series of internal audits.
Selecting and training internal auditors are important aspects of the process of implementation It is essential that Ben Thanh Tourist select internal auditors carefully
Management should select individuals from diverse sections of the company for auditing training instead of relying solely on a dedicated internal audit department This approach fosters a comprehensive understanding of formal management systems across the organization, mitigates the perception of internal auditing as a policing function, and encourages reciprocal auditing opportunities between suppliers and customers.
To enhance the effectiveness of internal audits at Ben Thanh Tourist, it is advisable to avoid selecting auditors from management This approach helps position internal audits as a system evaluation rather than a personnel appraisal Training for internal auditors should emphasize that the primary goal of internal audits is to add value to the organization, rather than to identify faults within the audited functions.
3.2.8 Step 8: Performance Improvement and Learning